Abstract Details

Title Efficacy of Cenobamate for Uncontrolled Focal Seizures: Post-hoc Analysis of a Phase 3, Multicenter, Open-Label Study

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) S1 - Epilepsy and Clinical Neurophysiology (EEG) 1 (2:08 PM-2:16 PM)

Poster/Presentation
Number 002

Background Cenobamate is an antiseizure medication (ASM) approved in the US for the treatment of adults with focal seizures.

Objective

Report post-hoc efficacy data from 10 US study sites from the long-term, global, open-label phase 3 safety study.

Design/Methods Patients 18-70 years old with uncontrolled focal seizures taking stable doses of 1-3 ASMs were administered increasing daily doses of cenobamate (12.5, 25, 50, 100, 150, 200 mg/day) over 12 weeks at 2-week intervals to a target dose of 200 mg/day. Further increases to 400 mg/day by 50-mg/day increments every other week were allowed during the maintenance phase. Dose adjustments of cenobamate and concomitant ASMs were allowed.

Results Two hundred forty patients with focal aware motor, focal impaired awareness, or focal to bilateral tonic-clonic seizure data while on treatment were evaluated (median duration of exposure 30.2 months). Mean baseline seizure frequency/28 days was 18.1 seizures/28 days (median 2.8). Of the 240 patients, 25.8% (62/240) had 100% seizure reduction for ≥12 months at the last visit; 36.3% (87/240) had 100% seizure reduction for ≥12 months at any visit. 100% seizure reduction durations of ≥6 and ≥3 months occurred in 35.0% (84/240) and 44.6% (107/240) of patients, respectively, at the last visit. Of the 240 patients, 177 (73.8%) were continuing on cenobamate at the last visit, and 60/177 (33.9%) had 100% seizure reduction for ≥12 months at the last visit. During the entire maintenance phase (maintenance population, n=214), ≥50%, ≥75%, ≥90%, and 100% responder rates occurred in 75.7% (162/214), 57.5% (123/214), 40.2 (86/214), and 13.6% (29/214) of patients, respectively. Most common adverse events among all patients included fatigue, dizziness, and somnolence.

Conclusions High rates of sustained 100% seizure reduction (≥12 months) were achieved with cenobamate in this post-hoc analysis from the long-term open-label study, further supporting durable seizure frequency reduction with cenobamate in adults with uncontrolled focal seizures.

Authors/Disclosures
Michael R. Sperling, MD, FAAN (Thomas Jefferson University) PRESENTER	Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. The institution of Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB Pharma. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medscape. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for International Medical Press. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Projects for Knowledge. The institution of Dr. Sperling has received research support from SK Life Science. The institution of Dr. Sperling has received research support from UCB Pharma . The institution of Dr. Sperling has received research support from Takeda. The institution of Dr. Sperling has received research support from Neurelis. The institution of Dr. Sperling has received research support from Engage Therapeutics . The institution of Dr. Sperling has received research support from Medtronic. The institution of Dr. Sperling has received research support from Cavion. The institution of Dr. Sperling has received research support from Xenon Pharma. The institution of Dr. Sperling has received research support from Cerevel. The institution of Dr. Sperling has received research support from National Institutes of Health . The institution of Dr. Sperling has received research support from DARPA. Dr. Sperling has received publishing royalties from a publication relating to health care. Dr. Sperling has received publishing royalties from a publication relating to health care. Dr. Sperling has received personal compensation in the range of $500-$4,999 for serving as a Vice President with Epilepsy Consortium .
Bassel W. Abou-Khalil, MD, FAAN (Vanderbilt University)	The institution of Dr. Abou-Khalil has received research support from Cerevel. The institution of Dr. Abou-Khalil has received research support from Xenon. The institution of Dr. Abou-Khalil has received research support from Otsuka. The institution of Dr. Abou-Khalil has received research support from UCB. The institution of Dr. Abou-Khalil has received research support from SK LIfe Science. The institution of Dr. Abou-Khalil has received research support from Neuroelectrics.
Sami M. Aboumatar, MD (Austin Epilepsy Care Center)	Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eisai. Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sunovion.
Perminder Bhatia, MD (Neuro-pain Medical Center Inc)	Dr. Bhatia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BIOHAVEN. Dr. Bhatia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ALLERGAN. Dr. Bhatia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for SK LIFE SCIENCES.
Victor Biton, MD (AEP)	Dr. Biton has nothing to disclose.
Pavel Klein, MD, FAAN (Mid-atlantic Epilepsy and Sleep Center)	The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Aquestive. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurelis. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB Pharma. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Life Sience. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eisai. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alliance. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Arvelle Therapeutics. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Aquestive. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eisai. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for UCB Pharma. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for SK Life Sciences. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Klein has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for PrevEp. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Fenwick . Dr. Klein has received research support from DOD/CURE.
Gregory Krauss, MD (Johns Hopkins University)	Dr. Krauss has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Arvelle. Dr. Krauss has received stock or an ownership interest from EpiWatch.
David G. Vossler, MD, FAAN (David G. Vossler MD FAAN FAES FACNS)	Dr. Vossler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biocodex Pharmaceuticals. Dr. Vossler has received personal compensation in the range of $0-$499 for serving as a Consultant for Biohaven Pharmaceuticals. Dr. Vossler has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Longboard Pharmaceuticals. Dr. Vossler has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Xenon Pharmaceuticals. Dr. Vossler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for SK Life Science. The institution of Dr. Vossler has received research support from SK Life Science. The institution of Dr. Vossler has received research support from Xenon Pharmaceuticals. The institution of Dr. Vossler has received research support from Longboard Pharmaceuticals.
Robert T. Wechsler, MD, PhD, FAAN (Consultants in Epilepsy & Neurology)	The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Otsuka. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Life Science. The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Aquestive. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Engage. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eisai. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eliem. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Epalex. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Engrail. The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Equilibre. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Raport. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurona. Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurelis. Dr. Wechsler has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Sunovion. Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for UCB. Dr. Wechsler has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Greenwich. Dr. Wechsler has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Eisai. Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Aquestive. Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for SK Life Science. Dr. Wechsler has a non-compensated relationship as a Board President with Epilepsy Foundation of Idaho that is relevant to AAN interests or activities.
Louis Ferrari	Louis Ferrari has received personal compensation for serving as an employee of SK Life science.
Marc Kamin, MD	Dr. Kamin has received personal compensation for serving as an employee of SK LIFE SCIENCE INC.
Mindy Grall, PhD, NP	Ms. Grall has received personal compensation for serving as an employee of Supernus Pharmaceuticals. Ms. Grall has stock in Supernus.
William E. Rosenfeld, MD, FAAN (Comprehensive Epilepsy Care Center for Children and Adults)	The institution of Dr. Rosenfeld has received personal compensation in the range of $500,000-$999,999 for serving as a Consultant for SK Life Science. Dr. Rosenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for SK Life Science.